VERITAS: A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00242580
• Collaborator: QLT Inc. (Industry)
• Enrollment: 111
• Location: 1
• Arms: 3

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration; Choroidal Neovascularization	Drug: Verteporfin photodynamic therapy; Drug: Pegaptanib; Drug: Triamcinolone acetonide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus Intravitreal Pegaptanib(Macugen®) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Verteporfin and Triamcinolone 1 mg Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy; After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; Other Names: Visudyne ; Drug: Triamcinolone acetonide; Triamcinolone acetonide administered by intravitreal injection.; Other Names: Kenalog-40®
Experimental: Verteporfin and Triamcinolone 4 mg Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy; After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; Other Names: Visudyne ; Drug: Triamcinolone acetonide; Triamcinolone acetonide administered by intravitreal injection.; Other Names: Kenalog-40®
Active Comparator: Verteporfin and Pegaptanib Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy; After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; Other Names: Visudyne ; Drug: Pegaptanib; Pegaptanib sodium 0.3 mg administered by intravitreal injection.; Other Names: Macugen

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline. [Baseline to Month 12]

   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.

Secondary Outcome Measures

1. Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12 [Baseline to Month 12]

   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.

2. Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months [Baseline to Month 12]

   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.

3. Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12 [Baseline to Month 12]

   BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.

4. Number of Participants Requiring Verteporfin Treatment Throughout the Study [Baseline to Month 12]

   Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.

5. Mean Change From Baseline in Total Area of Lesion at 12 Months [Baseline to Month 12]

   Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age >50

• all types of untreated subfoveal choroidal neovascularization secondary to AMD

• lesion size <5400 microns in greater linear dimension (GLD)

Exclusion Criteria:

• have a history of prior photodynamic therapy, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy

• known allergy to verteporfin, triamcinolone or pegaptanib

• have received prior treatment with Macugen, or other anti-angiogenic compound or any investigational treatment (e.g. Ruboxistaurin, Lucentis [ranibizumab], Retaane [anecortave acetate], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD

• have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (tip) of the retinal pigment epithelium or other hypoflourescent lesions obscuring greater than 50% of the CNV lesion

• have had previous pars plana vitrectomy in the study eye

Other protocol-specified inclusion/exclusion criteria applied.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigational Site	Austin	Texas	United States	78793

Sponsors and Collaborators

• Novartis Pharmaceuticals
• QLT Inc.

Investigators

• Study Chair: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Novartis patient recruitment website: Clinical trial information for patients and caregivers

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00242580
• Other Study ID Numbers: CBPD952E2202
• First Posted: Oct 20, 2005
• Last Update Posted: Mar 31, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by , ,: AMD; age-related macular degeneration; choroidal neovascularization
• Additional relevant MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Verteporfin; Triamcinolone diacetate

Study Results

Participant Flow

Recruitment Details	The protocol was amended to limit the sample size from 339 to 100. 111 entered the study and and were part of the 12 mo analysis. The study was subsequently terminated. The patients did not receive study drug during the second year of the study.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Period Title: Overall Study
STARTED	32	41	38
COMPLETED	22	29	24
NOT COMPLETED	10	12	14

Baseline Characteristics

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib	Total
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.	Total of all reporting groups
Overall Participants	32	41	38	111
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76 (9)	78 (8)	81 (6)	78 (8)
Sex: Female, Male (Count of Participants)
Female	18 56.3%	25 61%	20 52.6%	63 56.8%
Male	14 43.8%	16 39%	18 47.4%	48 43.2%
Region of Enrollment (participants) [Number]
United States	32 100%	41 100%	38 100%	111 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
Description	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.
Time Frame	Baseline to Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Measure Participants	32	41	38
Number [Percentage of Participants]	59.4 185.6%	63.4 154.6%	71.1 187.1%

2. Secondary Outcome

Title	Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
Description	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.
Time Frame	Baseline to Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Measure Participants	32	41	38
Number [Percentage of Participants]	31.3 97.8%	12.2 29.8%	28.9 76.1%

3. Secondary Outcome

Title	Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
Description	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.
Time Frame	Baseline to Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Measure Participants	32	41	38
Number [Percentage of Participants]	18.8 58.8%	2.4 5.9%	23.7 62.4%

4. Secondary Outcome

Title	Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
Description	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.
Time Frame	Baseline to Month 12

Outcome Measure Data

Analysis Population Description

Efficacy variable analyses were performed on the intent-to-treat (ITT) data set. The ITT set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Measure Participants	32	41	38
Number [Percentage of Participants]	6.3 19.7%	0 0%	13.2 34.7%

5. Secondary Outcome

Title	Number of Participants Requiring Verteporfin Treatment Throughout the Study
Description	Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.
Time Frame	Baseline to Month 12

Outcome Measure Data

Analysis Population Description

Observed data.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Measure Participants	32	41	38
Participants who received 1 treatment	11 (0) 34.4%	12 (0) 29.3%	10 (0) 26.3%
Participants who received 2 treatments	10 31.3%	15 36.6%	19 50%
Participants who received 3 treatments	9 28.1%	12 29.3%	5 13.2%
Participants who received 4 treatments	2 6.3%	2 4.9%	4 10.5%

6. Secondary Outcome

Title	Mean Change From Baseline in Total Area of Lesion at 12 Months
Description	Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.
Time Frame	Baseline to Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Measure Participants	32	41	38
Baseline	6.9178 (5.9455)	5.6400 (3.7154)	6.3011 (5.4794)
12 Months	6.8959 (7.6848)	5.8149 (4.6465)	8.6245 (7.1242)
Change from Baseline	-0.0219 (7.7026)	0.1749 (4.2357)	2.3234 (5.9370)

Adverse Events

Time Frame	12 months
Arm/Group Title	Verteporfin + 1 mg Triamcinolone		Verteporfin + 4 mg Triamcinolone		Verteporfin + Pegaptanib
Arm/Group Description	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.		Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.		Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
All Cause Mortality
	Verteporfin + 1 mg Triamcinolone		Verteporfin + 4 mg Triamcinolone		Verteporfin + Pegaptanib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Verteporfin + 1 mg Triamcinolone		Verteporfin + 4 mg Triamcinolone		Verteporfin + Pegaptanib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/32 (34.4%)		9/41 (22%)		10/38 (26.3%)
Cardiac disorders
ARRHYTHMIA	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
ATRIAL FIBRILLATION	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
CONGESTIVE HEART FAILURE	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
CORONARY ARTERY DISORDER	0/32 (0%)		2/41 (4.9%)		1/38 (2.6%)
HEART BLOCK	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
MYOCARDIAL INFARCT	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
Ear and labyrinth disorders
VERTIGO	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
Gastrointestinal disorders
CONSTIPATION	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
GASTRITIS	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
GASTROINTESTINAL DISORDER	1/32 (3.1%)		0/41 (0%)		2/38 (5.3%)
GASTROINTESTINAL HEMORRHAGE	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
PANCREATITIS	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
PEPTIC ULCER HEMORRHAGE	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
General disorders
CHEST PAIN	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
CYST	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
HERNIA	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
Hepatobiliary disorders
CHOLECYSTITIS	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
CHOLELITHIASIS	0/32 (0%)		1/41 (2.4%)		1/38 (2.6%)
Immune system disorders
ANAPHYLACTOID REACTION	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
Infections and infestations
INFECTION	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
PNEUMONIA	1/32 (3.1%)		2/41 (4.9%)		2/38 (5.3%)
Injury, poisoning and procedural complications
ACCIDENTAL INJURY	2/32 (6.3%)		1/41 (2.4%)		3/38 (7.9%)
Metabolism and nutrition disorders
HYPOKALEMIA	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
Nervous system disorders
CEREBRAL INFARCT	0/32 (0%)		2/41 (4.9%)		0/38 (0%)
CEREBRAL ISCHEMIA	1/32 (3.1%)		0/41 (0%)		1/38 (2.6%)
CEREBROVASCULAR ACCIDENT	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
ENCEPHALOPATHY	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
Renal and urinary disorders
ACUTE KIDNEY FAILURE	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
Respiratory, thoracic and mediastinal disorders
LUNG EDEMA	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
Vascular disorders
AORTIC STENOSIS	0/32 (0%)		1/41 (2.4%)		0/38 (0%)
ARTERIAL ANOMALY	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
ARTERIAL THROMBOSIS	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
ARTERIOSCLEROSIS	1/32 (3.1%)		0/41 (0%)		0/38 (0%)
DEEP THROMBOPHLEBITIS	0/32 (0%)		0/41 (0%)		1/38 (2.6%)
Other (Not Including Serious) Adverse Events
	Verteporfin + 1 mg Triamcinolone		Verteporfin + 4 mg Triamcinolone		Verteporfin + Pegaptanib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/32 (100%)		38/41 (92.7%)		30/38 (78.9%)
Blood and lymphatic system disorders
ANEMIA	0/32 (0%)		3/41 (7.3%)		1/38 (2.6%)
Cardiac disorders
CORONARY ARTERY DISORDER	0/32 (0%)		3/41 (7.3%)		1/38 (2.6%)
Ear and labyrinth disorders
TINNITUS	0/32 (0%)		0/41 (0%)		2/38 (5.3%)
Eye disorders
AMD PROGRESSION (Fellow eye)	5/32 (15.6%)		6/41 (14.6%)		7/38 (18.4%)
BLEPHARITIS (Fellow eye)	0/32 (0%)		0/41 (0%)		2/38 (5.3%)
CATARACT (Fellow eye)	3/32 (9.4%)		4/41 (9.8%)		2/38 (5.3%)
CONJUNCTIVITIS (Fellow eye)	2/32 (6.3%)		0/41 (0%)		2/38 (5.3%)
DRY EYES (Fellow eye)	1/32 (3.1%)		1/41 (2.4%)		4/38 (10.5%)
EYE DISORDER (Fellow eye)	0/32 (0%)		1/41 (2.4%)		2/38 (5.3%)
EYE ITCHING (Fellow eye)	2/32 (6.3%)		0/41 (0%)		0/38 (0%)
RETINAL DISORDER (Fellow eye)	2/32 (6.3%)		3/41 (7.3%)		2/38 (5.3%)
RETINAL HEMORRHAGE (Fellow eye)	1/32 (3.1%)		0/41 (0%)		2/38 (5.3%)
SUBRETINAL HEMORRHAGE (Fellow eye)	2/32 (6.3%)		0/41 (0%)		0/38 (0%)
VISION DECREASED (Fellow eye)	0/32 (0%)		1/41 (2.4%)		2/38 (5.3%)
ACUTE ELEVATED IOP (Study eye)	2/32 (6.3%)		7/41 (17.1%)		0/38 (0%)
AMD PROGRESSION (Study eye)	6/32 (18.8%)		8/41 (19.5%)		3/38 (7.9%)
BLEPHARITIS (Study eye)	1/32 (3.1%)		0/41 (0%)		2/38 (5.3%)
CATARACT (Study eye)	8/32 (25%)		10/41 (24.4%)		2/38 (5.3%)
CONJUNCTIVITIS (Study eye)	3/32 (9.4%)		0/41 (0%)		2/38 (5.3%)
DRY EYES (Study eye)	1/32 (3.1%)		2/41 (4.9%)		4/38 (10.5%)
EYE HEMORRHAGE (Study eye)	5/32 (15.6%)		7/41 (17.1%)		7/38 (18.4%)
EYE ITCHING (Study eye)	2/32 (6.3%)		0/41 (0%)		0/38 (0%)
EYE PAIN (Study eye)	2/32 (6.3%)		5/41 (12.2%)		2/38 (5.3%)
RETINAL DISORDER (Study eye)	1/32 (3.1%)		3/41 (7.3%)		1/38 (2.6%)
RETINAL EDEMA (Study eye)	3/32 (9.4%)		4/41 (9.8%)		0/38 (0%)
RETINAL HEMORRHAGE (Study eye)	2/32 (6.3%)		2/41 (4.9%)		0/38 (0%)
RETINAL PIGMENTATION (Study eye)	1/32 (3.1%)		1/41 (2.4%)		2/38 (5.3%)
SUBRETINAL HEMORRHAGE (Study eye)	3/32 (9.4%)		1/41 (2.4%)		2/38 (5.3%)
VISION ABNORMAL (Study eye)	4/32 (12.5%)		5/41 (12.2%)		3/38 (7.9%)
VISION DECREASED (Study eye)	1/32 (3.1%)		3/41 (7.3%)		3/38 (7.9%)
Gastrointestinal disorders
DIARRHEA	1/32 (3.1%)		2/41 (4.9%)		2/38 (5.3%)
DYSPEPSIA	2/32 (6.3%)		2/41 (4.9%)		1/38 (2.6%)
GASTROINTESTINAL DISORDER	1/32 (3.1%)		4/41 (9.8%)		3/38 (7.9%)
NAUSEA	4/32 (12.5%)		0/41 (0%)		3/38 (7.9%)
RECTAL DISORDER	0/32 (0%)		3/41 (7.3%)		0/38 (0%)
General disorders
PAIN	5/32 (15.6%)		4/41 (9.8%)		3/38 (7.9%)
PERIPHERAL EDEMA	2/32 (6.3%)		0/41 (0%)		2/38 (5.3%)
Infections and infestations
INFECTION	5/32 (15.6%)		2/41 (4.9%)		0/38 (0%)
BRONCHITIS	2/32 (6.3%)		0/41 (0%)		1/38 (2.6%)
PNEUMONIA	0/32 (0%)		1/41 (2.4%)		2/38 (5.3%)
RHINITIS	3/32 (9.4%)		6/41 (14.6%)		2/38 (5.3%)
SINUSITIS	2/32 (6.3%)		2/41 (4.9%)		1/38 (2.6%)
Injury, poisoning and procedural complications
ACCIDENTAL INJURY	0/32 (0%)		2/41 (4.9%)		5/38 (13.2%)
INJECTION SITE EXTRAVASATION	2/32 (6.3%)		0/41 (0%)		3/38 (7.9%)
Metabolism and nutrition disorders
HYPERLIPEMIA	2/32 (6.3%)		0/41 (0%)		2/38 (5.3%)
Musculoskeletal and connective tissue disorders
BACK PAIN	2/32 (6.3%)		3/41 (7.3%)		0/38 (0%)
ARTHRITIS	1/32 (3.1%)		4/41 (9.8%)		0/38 (0%)
Nervous system disorders
HEADACHE	4/32 (12.5%)		1/41 (2.4%)		3/38 (7.9%)
Psychiatric disorders
ANXIETY	0/32 (0%)		1/41 (2.4%)		2/38 (5.3%)
DEMENTIA	0/32 (0%)		2/41 (4.9%)		2/38 (5.3%)
INSOMNIA	0/32 (0%)		0/41 (0%)		3/38 (7.9%)
Renal and urinary disorders
URINARY TRACT INFECTION	2/32 (6.3%)		5/41 (12.2%)		5/38 (13.2%)
Respiratory, thoracic and mediastinal disorders
COUGH INCREASED	0/32 (0%)		3/41 (7.3%)		2/38 (5.3%)
LUNG DISORDER	1/32 (3.1%)		0/41 (0%)		2/38 (5.3%)
Skin and subcutaneous tissue disorders
CONTACT DERMATITIS	0/32 (0%)		0/41 (0%)		2/38 (5.3%)
PRURITUS	0/32 (0%)		0/41 (0%)		2/38 (5.3%)
SKIN DISORDER	2/32 (6.3%)		0/41 (0%)		0/38 (0%)
Vascular disorders
HYPERTENSION	7/32 (21.9%)		7/41 (17.1%)		2/38 (5.3%)

Limitations/Caveats

Secondary outcome measures were to be assessed at Month 6 and at 24 months. However, this study was not completed but terminated after all patients completed 12 months. Original safety was COSTART now mapped to SOC MedDRA.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.